Investigator-initiated clinical trial of bradycardia with transvenous vagus nerve stimulation catheters for supraventricular tachyarrhythmias
- Conditions
- Atrial fibrillation/Atrial flutter/Atrial tachycardia etc.
- Registration Number
- JPRN-jRCT2072230062
- Lead Sponsor
- Sakamoto Kazuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1) Patients aged 18 years or older at the time of obtaining consent
2) Patients with supraventricular tachyarrhythmia who undergo catheter ablation
3) Patients who have been fully informed, understood and given free written consent by the investigator or sub-investigator of the study
4) Patients with no cardiac dysfunction (left ventricular ejection fraction more than 50%) at level 1-1
1) Patients with anomaly of the superior vena cava
2) Patients with uncontrolled gastric and duodenal ulcers
3) Patients with implanted pacemaker (including leadless pacemaker), ICD (including S-ICD) and CRT
4) Patients with a temporary pacemaker inserted
5) Patients with contraindications to contrast media or severe allergy to contrast media
6) Patients with any kind of metal allergy
7) Patients with active bleeding
8) Patients with NYHA class IV
9) Patients with severe haemodynamic compromise, such as cardiogenic shock
10) Patients who are pregnant or potentially pregnant, or who wish to become pregnant during participation in the study
11) Patients participating in another clinical trial within 3 months of treatment
12) Patients who are judged by the investigator or sub-investigator to be unsuitable for this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in mean heart rate before and after stimulation
- Secondary Outcome Measures
Name Time Method Change in heart rate after stimulation <br>Percentage of target heart rate achieved<br>Hemodynamics changes<br>Clinical heart failure indicators<br>Number of adverse events <br>Number of failures